NCT05901636

A Clinical Study to Evaluate an Experimental Universal Influenza Vaccine, INFLUENZA G1 mHA, in Healthy Adults

A Randomized, Double-blind, Placebo-controlled, First-in-human Phase 1/2a Study to Evaluate Safety, Reactogenicity and Immunogenicity of a Universal Influenza (Uniflu) Vaccine With INFLUENZA G1 mHA in Healthy Adults

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 170 (actual)
• Sponsor: Janssen Vaccines & Prevention B.V. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The primary purpose of this study is to evaluate safety/ reactogenicity of INFLUENZA G1 mini-hemagglutinin stem-derived protein vaccine antigen (mHA), with or without Al(OH)3 adjuvant, in healthy adults greater than or equal to (\>=) 18 to less than or equal to (\<=) 45 years of age.

Conditions

• Influenza Prevention

Interventions

Type	Name	Description
BIOLOGICAL	INFLUENZA G1 mHA	INFLUENZA G1 mHA will be administered intramuscularly.
BIOLOGICAL	Placebo	Placebo will be administered intramuscularly.
BIOLOGICAL	Al(OH)3	Al(OH)3 will be administered intramuscularly.

Timeline

• Start date: 2023-05-17
• Primary completion: 2024-08-19
• Completion: 2024-08-19
• First posted: 2023-06-13
• Last updated: 2025-09-08
• Results posted: 2025-09-08

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated drug study